Montelukast is a very popular medication, especially for asthma patients. This is sold under popular brand names like Singulair. It is due to receive the FDA’s most serious “Black Box” warning!
According to the Food and Drug Administration, Montelukast is linked to “serious mental side effects.” This is why it should be off your doctor’s prescription unless they no other choice for their patients who are suffering from asthma. Montelukast is used as a maintenance treatment for asthma but is less preferred than inhaled corticosteroids.
However, this medication is not that useful for those with acute asthma attacks. Most doctors would prescribe this medication for allergic rhinitis and hives and can be used for longer periods.
FDA explains that Montelukast has dangerous side effects. This includes agitation, depression, sleeping problems, and possibly suicidal thoughts and actions. This drug was first approved in 1998 in the United States. It was made available as a generic medication. It was the 16th most prescribed medicine in the US in 2017 and had over 30 million prescriptions during that year.
According to Yahoo Finance, even with the impressive number, concerns were raised after a Dutch study in 2017 found that Montelukast has a correlation with depression and suicidal thoughts in children.
In 2018, an Australian Broadcast Company reported that the Therapeutic Goods Administration (TGA) which is the country’s equivalent to FDA, received over 160 complaints from 2000 to 2017 of ‘psychiatric episodes in children and adolescents. This is why TGA immediately placed warnings on boxes regarding the possible side effects of the drug.
In the same year, approximately 9 million patients of different ages were prescribed with Montelukast in the United States. And out of this number, 2.5 million were children who are below 17 years old.
FDA reports that this product caused a wide variety of mental health side effects. Suicide is one of the major concerns that are linked to users who are taking Montelukast. In some of these episodes, it took place during the Montelukast treatment. But when the medication was stopped, the side effects subsided. However, there are still cases that mental health effects can develop with prolonged use of the product even after stopping the intake.
FDA explains saying, “Because of the risk of mental health side effects, the benefits of montelukast may not outweigh the risks in some patients, particularly when the symptoms of the disease may be mild and adequately treated with other medicines. In addition, many health care professionals and patients/caregivers are not aware of the risk of mental health side effects despite the existing warnings in the prescribing information.”
FDA further explains saying, “Due to the wide availability of alternative safe and effective allergy medicines with long histories of safety, we have reevaluated the risks and benefits of montelukast and have determined it should not be the first choice treatment particularly when allergic rhinitis symptoms are mild… we continue to receive reports of mental health side effects reported with montelukast use. Consistent with our prior evaluations, a wide variety of mental health side effects have been reported, including completed suicides.”
FDA also advise parents who have children that were prescribed with Singulair to raise this concern with their child’s pediatrician. Talk about stopping the medication as soon as possible. This is extremely urged to parents with children who are showing any sorts of behavioral or mood-related changes while taking the product.
